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Fda 20, Britain 7, Us 6, U.s. 4, China 3, England 1, America 1, David Cameron 1, Obama 1, Fdasi 1, Kennedy 1, Jim Lehrer 1, Turkey 1, Counterfeited 1, Gas 1, Brig 1, Online 1, Fda Logos 1, United States 1, Fdasia 1,
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  CSPAN    International Programming    Series/Special.  

    October 3, 2012
    7:00 - 7:30am EDT  

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remember the pause? he said he wanted to listen. and what happened? the gp's said no. the nurses said no. the pediatrician said no. the radiologist said no. the patients said -- >> no. >> and the burst people said -- >> no spent and what did he do? he broke his solemn contract with the british people, a contract that can never be repaired. [applause] >> let me tell you what i hate about this re- organization. i hate the ways. i hate the waste of billions of pounds at a time when the nhs
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has its most difficult settlement for a generation. i hate the fact that there are five and a half thousand, five and a half thousand fewer nurses then when david cameron came to power. think of what he could have done if he hadn't spent billions of pounds on the top down we organization and used the money to employ nurses rather than sacking them. [applause] but here's what i hate most of all. here's what i hate most of all. it's the whole way they designed the nhs reorganization. based on the model of competition that there was in a privatized utility industry, gas, energy and water. what does that tell you about these tories?
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what does that tell you about the way they don't understand the values of the nhs? the nhs isn't what like the gas, water industry. the nhs is the pride of britain. it is based on whole different set of values for our country. it just shows that these old adage is true or not than it ever was, you just can't trust the tories on a national health service. [applause]
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[applause] >> so let me be clear, let me be clear, the next labour government will end the free market experiment. it will put the right principles back in the heart of the nhs and it will repeal the nhs bill. [applause] friends, this is where i stand. this is what i am. this is what i belief. this is my faith. i was talking to my mom this morning, as you do before a big speech -- [laughter] and she reminded me that her mother was born in a small
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polish village in 1909. i went back to the village with my mom about a decade ago. about 2000 people live there. it was quite an event, having people from england, over. you feel a long way from the village and what my parents experienced to this stage today. you see, britain has given my family everything. britain has given my family everything. britain and the spirit, determination, the courage of the people who rebuilt britain after the second world war, and now the question is asked again, who in this generation will rebuild britain for the future? who can come up to the task of rebuilding britain? friends, it falls to us. it falls to us, the labour party, as it has fallen to
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previous generations of labour party pioneers, to lead our country a better place than we found. never to shrug our shoulders of injustice and say, that is the way the world is. to come together, to join together, to work together as a country. it's not something possible dream. we have heard it. we've seen it. we felt it. that is my face. one nation, a country for all with everyone playing their part. a britain we'd rebuild together. thank you very much. [applause]
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than. [applause] [cheers and applause] >> the brookings institution host a panel later today that will compare the leadership styles of the president obama and mitt romney. we will have live coverage here ohereon c-span2 beginning at 9 . eastern. >> when nation's cheat in trade,
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and china has cheated, i will finally do something that the president has not been willing to do which is call them on the carpet for it and label them a currency manipulator. >> we have brought more trade cases against china in one term than the previous administration did in two. and by the way, we have been winning those cases. >> tonight president obama and mitt romney meet in the first presidential debate. jim lehrer moderates from the university of denver. watch and engage with see them with our life in the brig at 7 p.m. eastern followed by two ways to watch the debate at nine. on c-span both candidates on screen the entire debate. on c-span2 a multi-camera version of the debate. and following, your reactions, calls, e-mails and tweet. follow our live coverage on c-span, c-span radio and online at c-span.org. >> ahead of the food and drug administration spoke at a conference on counterfeit prescription drugs.
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she discussed the new fda initiative to educate consumers, called bsafe our ex. this conference was hosted by the partnership for safe medicine. the fda commissioner's remarks are 20 minutes. >> thank you. it's really a pleasure to be here once again with the partnership for safe medicines. this is a really important topic to me personally and professionally, and really given our shared shared commitment to make our nation drug supply safe, effective, secure and high quality as possible, the work with a partnership is very, very meaningful to us. they have been an important and reliable ally for fda, and we so value the work of the
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partnership. given the enormity of the challenge in front of us to protect the american people from contaminated counterfeit, substandard and other unsafe drugs at a time when the marketplace is global, when the speed of communications is near instantaneous and the money to be made through deception and fraud, it seems almost -- almost limitless. our goal is to make our already strong partnership even stronger and more effective. i'm also pleased to have this opportunity to talk to someone or some public health, law enforcement, industry and government about this pressing and really important public health challenge. and i want to offer an update on the progress that would make sense unless lesser which already was two years ago, which i don't know where the time goes. but we have been busy and have improved our strategies and our engagement to address the
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increasingly complex supply chain that we now regulate. then i want to tell you about be safe rx, know your online pharmacy which is our new national campaign that you've heard a little bit about, and it's designed to educate consumers who purchase medications over the internet. president kennedy like to say we must think and act not only for the moment but for our time. and the 21st century is really our time. and as i've also suggested and we are seeking to address a serious and far-reaching problem. one that sadly is growing, and one that is very real consequences now and for the future. we need to work together on effective and sustainable strategies that will enable us to stay ahead of the many avenues that criminals are finding to profit by putting the health and lives of our american citizens at risk. so over the last two years,
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we've continued to put in place administrative, law enforcement, technological and collaborative tools that we think are necessary to win this battle against 21st century snake oil peddlers. since i was last with you, fda issued our pathway to global product safety quality and global engagement report, and this addresses the complex and profound ways globalization has changed the drug supply chain. our new operating model relies on building global coalition of regulatory authority, enhanced intelligence and information sharing systems, data-driven risk analysis, and a smart allocation of resources through partnerships. more specifically, we are working with the global public health community to strengthen regulatory capacity here and around the world, harmonize science-based standards, utilize
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risk-based monitoring and inspection, improve global surveillance, preparedness and emergency response, and to advance regulatory science. also, two years ago i told you that drug security was a top priority at fda. well, we now have the office of drug security integrity and recall that is located in cedar's office of compliance, up and running, playing the resources of strategies to the problems of counterfeiting, intentional adulteration, diversion, cargo theft, and other threats to the drug supply chain. but perhaps most important development is the passage of the food and drug administrations safety and innovation act of 2012, or what we fondly called fdasi. to improve patient access to new and better treatments, and to
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alleviate drug some shortages. fdasia also gives the fda important new authorities to protect the integrity of the to -- drug supply chain. thanks to fdasia we will receive enhanced information about drug manufacturers and the establishment and have the authority to develop a risk-based scheduled to inspect those establishment. we will be able to obtain records prior to an inspection, and fda can refuse drugs to the u.s. which were manufacturing for the substance that delayed, denied, limited or refused fda inspection. fda also now has the authority to put in place new processes to allow for the destruction of small mail packages of illegal drugs, which will deter purchases from illegal foreign internet pharmacies. under fdasia, communications with foreign regulatory agencies will improve.
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the definition of good manufacturing practices is more explicit, including quality systems and risk management. and registration of commercial importers is required. importantly, fdasia also requires notification to fda if a drug is stolen or counterfeited or if the use of the drug may result in serious injury or death. additionally as you've already heard, most likely for my colleagues who spoke earlier, fdasia provides for hands criminal penalties for counterfeiting and makes explicit fda's extraterritorial jurisdiction. counterfeit unadulterated medical products are not new problems, but we do have to address them in some new ways. the fda, in fact, as scott mentioned was created back in 1906 in order to address serious concerns about adulterated foods and medical treatments. but what has really changed is
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globalization. today, approximately 80% of the manufacturing site for the active ingredients in fda approved drugs are outside of the united states, and about 40% of finnish drugs that are on u.s. shelves may be being used by you are actually coming from foreign establishments that are registered with fda. in total there are about some 300,000 different facilities spread across 150 countries that are sending fda regulated products to our shores. globalization has really changed the challenges before us. because of the increase in numbers, but also globalization means longer and much more complex supply chains that can start almost anywhere. and it's every step along this global supply chain, from raw materials to finished product, there are it a point in
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opportunities for products to be contaminated, diverted, counterfeited, or in some other way adulterated by a web of middlemen such as we packagers and distributors. the american people have every right to expect that medicines they rely on will, in fact, be what the package and label say they are. and that the medicines have been carefully evaluated by fda for safety, efficacy and quality. but unscrupulous players continue to try to introduce counterfeit and intentionally adulterated drugs. we know these can be dangerous because they contain too much, too little, the wrong active ingredient, or no active ingredient at all, in addition to being mislabeled. the wrong active ingredient can be harmful. the wrong active ingredient or no active ingredient means the patient is not getting the treatment they need and could even experience unexpected side effects or serious, even lethal,
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drug interactions. drugs can also be adulterated if they are not handled, stored or transported properly. and back in 2009, some of you may remember there was a case where insulin which requires refrigeration was stolen, stored in properly, lost its potency, and then it was reintroduced into the supply chain. and when it was reintroduced in patients who needed it, used it, it failed to control their glucose, putting them seriously at risk. although thankfully cases of counterfeit and intentionally a adulterated drugs reaching the american consumer are rare, they are not unheard of and they do pose a real harm. again, many of you know doubt recall back in 2008 when the fda learned that a large number of patients who were taking heparin were experiencing some unusual
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allergic reactions, and in a few cases there appeared to be related deaths. our scientists determined that the contaminant known by the initials oscs had intentionally been added to the heparin. just as important, we at the fda identified preliminary testing methods to quickly distinguish contaminated from an contaminated heparin, and requested that manufactures and suppliers of the drug test their supplies using the new methodology. enabling really what was quite a rapid response to this unexpected contamination, and giving us and our colleagues and stakeholders the tools they needed to make a difference. and following the heparin crisis, learning from a deeper understanding of the nature of this kind of adulteration, we decided to rank more than 1000 active pharmaceutical ingredients in order of their respective risk of economically
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motivated adulteration. so we're trying to be as proactive as possible in preventing drug counterfeiting contamination and adulteration. but we do see problems. in april of this year, a counterfeit version of the cancer drug showed up in the united states. it is approved in turkey. it's related to the drug that is approved here, but it isn't approved here and in and of itself that makes it illegal to have it be sold here. but to make matters worse we found that the counterfeit did not even contain the active ingredient. and laugh at him only a few months after fda had to notify medical practices and multiple states that they purchase unapproved foreign drugs, which might also have included a counterfeit version of the same drug.
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inmate of this year fda issued a warning to the public about a counterfeit version of adderall to a drug that is used to treat adhd. and this drug was being sold over the internet. our lab tests show that none of adderall for active ingredients were in the counterfeits, and the fact is counterfeit contained the wrong active ingredients altogether. also in the last few years we've seen counterfeit over-the-counter diet pills, poisoned cough medicine in parts of central america, as well as dairy products in pet food imported from china and contaminated with melamine. threats that compromise drug integrity are a global problem, and no one regulatory authority a loan, working in a vacuum, and possibly curtail these threats. our success or failure in addressing this global challenge will depend on collaborate with public health and regulatory
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partners around the world. and we are engaging in some exciting project. one is that chinese officials or deploying mobile labs and portable devices that screen for counterfeit and adulterated drugs. partnerships of this kind and many others are indispensable to fda's mission of keeping medicines safe. but science and technology in really is very fundamental to some of what we are now trying to do. at fda we have an extraordinary team of scientists and engineers who are developing tools to improve detection of suspected adulterated and counterfeit drugs, before these dangers commodities get into the hands of consumers. and earlier this month i had the opportunity to talk about and help demonstrate a new device recently developed, patented, by our rented chemistry syndicate. the device is called the counterfeit detection device
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number three. and we have teased our colleagues that we might want to have a slightly better name for this, you know, iphone or android might sell more. but it is really a very exciting device. because it's low cost compared to other analytical devices but it provides a huge value in our efforts to quickly screen for potential problem products but most importantly, it allows for real-time on site comparisons of authentic drugs and has already proven very useful for examining suspected counterfeit drugs at some of our busy international mail facility. the ce3 is only one example of the cutting edge of science and technology at fda is developing and deploying. to quickly discover and stop counterfeits and intentionally adulterated drugs when they're trying to make their way into
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the u.s. drug supply. but as much as i believe in the power of science and statistical analysis and tech knowledge to address these problems, for as much as i believe in the necessity of tough law enforcement, and i do, and as much as i believe in the benefits of collaboration such as with the partnership for safe medicines, i also believe that we must unleash the power of an educated public in promoting good health and in helping to protect themselves from unsafe drugs. went armed with the right information, consumers can take control and leave the purveyors of adulterated and counterfeit drugs holding worthless products that they can't sell to informed americans who won't be scammed. while we worked with manufacture to ensure that safe, effective, high quality drugs are available to u.s. consumers, and it's a
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fundamental part of our mission and our charge, we continue to find that bad actors, people who are making counterfeits or other substandard drugs, who don't care about who they are harming and to bring profit over public health, we still find these bad actors. and while we try to address them in many ways, we feel we need a more proactive approach to combating their nefarious efforts. and one important way to help consumers take ownership of their own health by giving them the facts they need about whether medicines come from and how to make informed choices. combined with this is a challenge of the internet. it's the tool of choice for bogus pharmacies, which adds another layer of complexity in the fight against the sale of counterfeits intentionally adulterated drugs and other approved product. and based on a recent fda survey we found out that about 23% of
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surveyed adults that were internet users were buying prescription drugs over the internet. but about 30% of the responders said that they had no real idea how to make sure that the pharmacies you are purchasing from, in fact were safe and legitimate. and so that's why we decided to do this campaign, fda's be safe rx campaign that was announced today. the objectives of be safe rx r., one, to raise awareness of the health risks of ordering prescription medicine through fraudulent online pharmacies. two, to teach consumers what steps to take to help identify safe, legal online pharmacies, and three, to motivate consumers to use the new resources that we are making available so that they will make informed choices to protect their health. buying certain medicines over
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the internet is not enough itself illegal here and ordering prescription medicines through mail order pharmacies constantly provide convenience while also saving time and money. that said, illegal online pharmacies number in the thousands, possibly as few as 3% meeting federal and state laws or practice standards according to a review that was done at the national association of boards and pharmacy. more importantly, people who do buy medications from fraudulent come in illegal online pharmacies are often unknowingly putting their health and the health of the families at serious health risk. these fake online pharmacies is cut rate prices, phony return addresses, 800 number's, and elaborate marketing schemes with authentic looking websites to sell their goods. some even include fda logos in their advertising.
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the fda doesn't have anything to do with approving or licensing pharmacies. licensing a pharmacy as you probably know is actually done at the state level. these websites also tend to offer deep discounts with prices that people might think seem too good to be true. and that is probably because in fact it is too good to be true. so be safe rx is trying to focus on some of these issues, understand what american consumers are looking for, but also help them to help themselves to be safe. our new website is www.fda.gov be safe rx. we provide important information about the risks and provide advice how consumers can protect themselves from fraudulent online pharmacies.
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patients and caregivers can go to the site to better understand the potential risk of what they are buying and who they are buying from when using the internet. the campaign also includes fact sheets and other consumer friendly tools to help patients and caregivers make smart, safe choices when purchasing medications online. but my more general message to the public is this. know the difference between a safe online pharmacy and an unsafe one. consumers should be wary of any pharmacy that allows you to buy without a prescription. that since spam or unsolicited e-mails offering deep discounts. that ships prescriptions worldwide or from a foreign country, or is located outside the united states. on the other hand, a safe online pharmacy will require a prescription from your doctor or other health care professionals and will be located and licensed in the united states. we want the american people to
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know the risks, to know the signs and to know their online pharmacy before they buy, and be safe rx will really help we hope with all three. my closing comment is for my fellow physicians. health professionals can play a very important role in making sure their patients are not purchasing unsafe medicines online. if the medicine doesn't seem to be having the desired effect, ask your patient what he or she actually obtained the prescription. and when you talk to your patient, take a few minutes to warn them about potential dangers of purchasing medicines over the internet. in the age of the internet, advice about online pharmacy and the availability of be safe rx should be part of the conversation that doctors and other health professionals have with their patients. th

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